I-China iye yaba yindawo ebalulekileyo yehlabathi ukwenza imveliso kunye nokuthumela kwelinye ilizweizixhobo zonyango. Ngoluhlu olubanzi lweemveliso kunye namaxabiso okhuphiswano, eli lizwe litsala abathengi kwihlabathi liphela. Nangona kunjalo, ukungenisa izixhobo zonyango ezivela e-China zibandakanya ukuqwalaselwa okuninzi okuthe kratya ukuqinisekisa ukuthotyelwa, umgangatho kunye nokusebenza kakuhle. Nazi iindlela eziphambili eziphambili zokulandela xa zingenisa izixhobo zonyango ezivela eChina.
1. Qonda ukuthotyelwa komthetho
Ngaphambi kokungenisa elizweni, kubalulekile ukuqonda imimiselo yomibini nezamanye amazwe. Amazwe amaninzi, kuquka amalungu e-US nase-European Union, afuna izixhobo zonyango ukuze zidibane nemigangatho engqongqo. Oku kuthetha ukuba nasiphi na isixhobo sonyango ongenisayo e-China kufuneka sithobele le migaqo ukuqinisekisa ukhuseleko lwezigulana kunye nomgangatho wemveliso. Ukuqinisekiswa okuqhelekileyo ukukhangela kubandakanya:
Imvume ye-FDA yokusetyenziswa kwentengiso yase-US.
-Ukundwendwela kwezixhobo ezenzelwe i-European Union.
- ISO 13485 Isiqinisekiso, esibandakanya iinkqubo zokulawulwa komgangatho ngokukodwa kwizixhobo zonyango.
Cela iZiqinisekiso ezivela kubathengisi abanokubakho kwangethuba kwinkqubo yothetha-thethano. Ukuqinisekisa ukungqinisisa kunokusindisa ixesha kunye nemiqobo enokubakho.
IQumrhu leQela leShanghai ngumthengisi oqeqeshiweyo kunye nomenzi ngamava atyebileyo, kwaye uninzi lweemveliso zethu zezo, i-ISO13485, imvume ye-FDA, kunye neemveliso zethu zithunyelwa kumazwe amaninzi kwihlabathi liphela.
2. Jonga amava omthengisi kunye nodumo
Amava omthengisi kwizixhobo zonyango ezibalulekileyo zibalulekile. Ukukhetha umthengisi ngerekhodi eyomeleleyo kwishishini lezixhobo zezonyango kunceda ekuqinisekiseni ukuba bayaziqonda iimfuno nemigangatho ebekiweyo kwimarike yakho. Nanga amanyathelo okuvavanya ukuthembeka komthengisi:
-Cela umthengisi ukuba anike igama labathengi ababesebenza ngaphambili.
-Buza abathengisi ukuba banamava kwiimarike zakho ngaphambili.
-Ndityelele umzi-mveliso wakhe okanye iofisi yabo. Ukuba kunokwenzeka, ukubona iinkqubo zabo zokwenza kunye neenkqubo zolawulo ezisemgangathweni.
Ukusebenza nabathengisi abanamava kunyusa amathuba okufumana izixhobo ezithotyelweyo kunye nezixhobo ezisemgangathweni.
3. Vavanya imveliso yemveliso kunye nokuqhuba ngenkuthalo efanelekileyo
Umgangatho awunakuphikiswa xa kufikwa kwizixhobo zonyango, njengoko ezi mveliso zempilo ngokuthe ngqo kwimpilo nokhuseleko. Ukuqhutywa kokukhuthala kubandakanya:
-Ukhumbula iisampulu ukuvavanya umgangatho wemveliso ngaphambi kokubeka iodolo enkulu.
-Ukcela uvavanyo lombutho wesithathu kwiiarhente ezinje nge-SGS okanye i-TÜV, enokuthi ihlole iimveliso kumanqanaba ngamanqanaba ngamanqanaba ahlukeneyo, ukusuka kwimveliso ukuya phambili.
-Ukuqhuba uvavanyo lwe-lab ukuba kuyasebenza, ngakumbi ukufumana izixhobo ezinzima okanye izixhobo zomngcipheko omkhulu, ukuqinisekisa ukuba ziyafezekisa imigangatho yelizwe lakho.
Unxibelelwano olungaguqukiyo nomthengisi olwaluncedo malunga nokulindelwa komgangatho kunye nokuhlolwa rhoqo kunokunceda ukukhusela imiba enxulumene nomgangatho.
4. QAPHELA IMIQATHANGO YOKUTHENGA NOKHUSELEKO LWEZIMALI
Amagama oshicilelo acacileyo kukhusela wena nomnikezeli. Ababoneleli baseTshayina ngokubanzi bakhetha idiphozithi ngaphambi kwemveliso kunye nebhalansi eseleyo ngaphambi kokuhambisa. Ezinye iindlela zokuhlawula ngokukhuselekileyo zibandakanya:
-Ileta yetyala (L / C): Oku kunika ukhuseleko kuwo omabini amaqela kwaye kuyacetyiswa kwi-odolo emikhulu.
- Udluliselo lwefowuni (t / t): Nangona isetyenziswa ngokuqhelekileyo, kufuna ukuthembana njengoko kubandakanya intlawulo kwangaphambili.
Qinisekisa ukuba uyayiqonda imigaqo yokuhlawula abathengisi kwaye ubandakanya izivumelwano ezicacileyo kwimali ebunjiweyo okanye imbuyekezo kwimeko yomgangatho okanye imicimbi yokuhambisa.
5. Cwangciso lweenkcukacha zokuhambisa kunye neenkcukacha zokuhambisa
Izixhobo zezonyango zifuna ukuphathwa ngokufanelekileyo kwaye zihlala zifuna ukupakishwa okhethekileyo ukuqinisekisa ukuba bafika bengafanelekanga. Ukusebenzisana noMboneleli wakho kunye noMbutho weLog ukuze baqonde iindlela zokuhambisa, iimfuno zesiko, kunye namaxwebhu. Ezinye iingcebiso ekufuneka ziqwalaselwe zibandakanya:
-Khetha iZinto ezilungileyo (umz.
- Ukuqinisekisa ukupakisha kunye nelebheli imigangatho yokuthobela imigaqo yelizwe kunye nokungenisa elizweni.
Ukulungiswa kwemvume yesiko ngokuqinisekisa ukuba onke amaxwebhu achanekile, kubandakanya izatifikethi, ii-invoice, kunye noluhlu lokupakisha.
Ukukhetha iqabane elinamava ezinamava kunokunceda ukuthoba inkqubo yokucocwa kwesiko kunye nokunciphisa ukulibaziseka okungalindelekanga.
6. Phuhlisa isicwangciso solawulo lomngcipheko
Ukungenisa kwelinye ilizwe, ngakumbi kwicandelo lezonyango, kuza nemingcipheko yemvelo. Eminye imingcipheko yokuqwalaselwa kukulibaziseka, imiba esemgangathweni, okanye utshintsho olulawulayo. Ukuphunyezwa kwesicwangciso solawulo lomngcipheko kubalulekile ukunciphisa ezi ntsimi:
- Yahlula abathengisi bakho ukuba baphephe ukuthembeka ngaphezulu kumthombo omnye. Oku kubonelela ngeendlela zokhetho lokugcina ukuba kuvela imiba kunye nomthengisi omnye.
-Fumisa isicwangciso senkathako sokulibaziseka okungalindelekanga, njengokugcina isitokhwe esongezelelweyo okanye ukusebenza nabathengisi bendawo xa kunokwenzeka.
- Hlala uhlaziywe ngotshintsho olulawulayo olunokuba nefuthe kwinkqubo yakho yokungenisa okanye imigaqo yezixhobo ezivunyelwe kwimarike yakho.
Ukulawula umngcipheko obonakalayo unokungalondoloze ixesha, imali, nokukhusela udumo lwakho lweshishini kwixesha elide.
Ukuqukumbela
Ukungenisa izixhobo zonyango e-China kubonelela ngeenzuzo zexabiso, kodwa kufuna ukucwangciswa ngononophelo kwaye uphaphile ukuqinisekisa umgangatho wemveliso kunye nokuthotyelwa komthetho. Ngokulandela la manyathelo amathandathu asebenzisekayo - agxile ekuthobeleni, udumo lwabathengisi, ukhuseleko lwentlawulo, ukhuseleko lwentlawulo, ukucwangciswa kwempahla, kunye nolawulo lomngcipheko - unokuseka inkqubo yokungenela ingeniso ethembekileyo. Ukusebenzisana nomxhasi weqela le-Shanghai, i-tyhenter ye-shangstaine yecandelo lezonyango, inokunceda ukunciphisa umngcipheko kwaye anikezele ngoxolo lwengqondo, ukuqinisekisa ukuba izixhobo zezonyango ezingeniswayo zihlangabezana nemigangatho ephezulu kwaye ufikelela kubathengi bakho ngexesha.
IXESHA LOKUQALA: UNv-04 ukuya ku-024